Department of Ophthalmology, San Rafael Hospital, Madrid, Spain.
Instituto Oftalmológico de Madrid, Madrid, Spain.
Int Ophthalmol. 2023 Dec;43(12):4491-4502. doi: 10.1007/s10792-023-02850-8. Epub 2023 Aug 17.
To analyze and report the long-term outcomes in terms of efficacy and safety of eyes implanted with the spherical version of a foldable iris-fixated phakic intraocular lens (pIOL) for the correction of myopia.
Retrospective analysis of the results of 56 eyes of 32 patients (age, 19-45 years) who underwent implantation of the spherical model of the Artiflex pIOL (Ophtec B.V., Groningen, The Netherlands) for the correction of myopia. Visual, refractive, biometric, intraocular pressure (IOP) and corneal endothelial changes were evaluated during a long-term follow-up: 2, 7, 10 and 12 years for more than 50, 30, 20 and 10 eyes, respectively.
At 4 weeks postoperatively, a significant reduction of manifest sphere and spherical equivalent (SE), with a significant improvement of uncorrected distance visual acuity were found (all p < 0.001). No significant changes were found during the rest of follow-up in sphere (p ≥ 0.072). The percentage of eyes with SE within ± 1.00 D was over 83% during the whole follow-up. A non-significant trend to IOP increase was observed at 4 weeks postoperatively (p = 0.530), with a significant reduction at 1 year after (p = 0.039) and no significant changes during the rest of follow-up (p = 0.180). There was a significant reduction of anterior chamber depth at 4 weeks after surgery (p < 0.001), with no significant changes during the following 9 years of follow-up (p = 0.118). However, an additional significant decrease of this parameter was observed between 10 and 13 years after surgery (p = 0.027). Mean endothelial cell loss changed from 2.01 ± 4.49% at 4 weeks after surgery to 9.11 ± 2.24% at the end of the follow-up. No complications were reported during the follow-up.
Myopia correction with the Artiflex pIOL is an effective and safe procedure in the long term.
分析和报告植入可折叠虹膜固定型有晶状体眼人工晶状体（pIOL）球形版本矫正近视的长期疗效和安全性。
回顾性分析 32 名患者（年龄 19-45 岁）56 只眼植入荷兰 Ophtec B.V.公司生产的 Artiflex pIOL 球形模型矫正近视的结果。在长期随访中评估视力、屈光、生物测量、眼压（IOP）和角膜内皮细胞变化：2、7、10 和 12 年时，超过 50、30、20 和 10 只眼分别随访 4 周、4 周、4 周、4 周。
术后 4 周时，发现明显降低了视力球镜和等效球镜（SE），明显提高了未矫正距离视力（均 P < 0.001）。在其余随访中，球镜无明显变化（P ≥ 0.072）。整个随访期间，SE 在±1.00 D 内的眼数超过 83%。术后 4 周时，IOP 呈升高趋势，但无统计学意义（P = 0.530），术后 1 年时明显降低（P = 0.039），其余随访时无明显变化（P = 0.180）。术后 4 周时前房深度明显降低（P < 0.001），随访 9 年内无明显变化（P = 0.118）。然而，术后 10-13 年时该参数又有显著下降（P = 0.027）。内皮细胞平均丢失率从术后 4 周的 2.01 ± 4.49%降至随访结束时的 9.11 ± 2.24%。随访期间无并发症发生。
长期来看，植入 Artiflex pIOL 矫正近视是一种有效且安全的方法。
